Multiple Sclerosis Clinical Trial
— TEAAMSOfficial title:
Promotion of Exercise Behavior Among Rural-Residing African-Americans With Multiple Sclerosis
The proposed project involves a high-quality randomized controlled (RCT) design that examines the effects of a remotely-delivered, racially-tailored exercise training program for immediate and sustained improvement in walking dysfunction, symptoms, and health-related quality of life (HRQOL) among African-Americans with MS residing in rural environments. The primary analysis will test the hypothesis that those who are randomly assigned into the intervention condition (i.e., exercise training) will demonstrate (a) improvements in outcomes from baseline that (b) are sustained over 4-months of follow-up compared with those in the control condition (i.e., stretching).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | August 2025 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - English as primary language - Identify as African-American or Black - Age of 18 years or older - Diagnosis of MS - Relapse free in the past 30 days - Internet and email access - Willingness to complete the outcome questionnaires - Willingness to undergo randomization - Insufficient physical activity (not meeting current physical activity guidelines based on GLTEQ) - Mild-moderate ambulatory disability (MSWS-12 score between 25-49 & PDDS score between 2-4) Exclusion Criteria: - Individuals not meeting above inclusion criteria - Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ). |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | Bristol-Myers Squibb, University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exercise Behavior | Godin Leisure Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in exercise behavior. | Changes in exercise behavior from Baseline, after 4-month intervention period, and 4 months after intervention cessation. | |
Primary | Walking Dysfunction | Multiple Sclerosis Walking Scale-12 (MSWS-12); scores range between 0 (min) and 100 (max), higher scores reflect greater walking problems. | Changes in walking scores from Baseline, 4-months, and 8-months. | |
Secondary | Disability | Patient Determined Disease Steps (PDDS) scale; scores range between 0 (min) and 8 (max), higher score reflect greater perceived disability. | Changes in disability scores from Baseline, 4-months, and 8 months. | |
Secondary | Fatigue Severity | Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity. | Changes in fatigue from Baseline, after 4-month intervention period, and 4 months after intervention cessation. | |
Secondary | Depressive Symptoms | Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms. | Changes in depressive symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation. | |
Secondary | Anxiety | Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms. | Changes in anxiety symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation. | |
Secondary | Health-related Quality of Life (HRQOL) | Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate greater impact of disease on daily function (i.e. worse outcomes). | Changes in quality of life from Baseline, after 4-month intervention period, and 4 months after intervention cessation. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT02845635 -
MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
|